Meeting Sid Wolfe, the Most Dangerous Man in Pharmaceutical Safety
From Bitter Pills by Stephen Fried (Bantam 1998) p 178–180
I thought it was time I finally met the man whose name had become so synonymous with pharmaceutical muckraking. So I arranged to see him at his office in Washington’s Dupont Circle area, in the building where Ralph Nader’s other organizations were also housed. I waited for Wolfe in a small, jammed law library with a conference table.
For the past twenty-five years, Dr. Sidney Wolfe has been the most consistently controversial man in medicine. Calling him a medical Ralph Nader is almost too easy, because he is much more of a fixture in health care than Nader is in the various worlds he has invaded. More accurate, perhaps, is the description I once heard from one of the world’s most respected pharmacology researchers. He called Wolfe “the Malcolm X of medication, and he meant it in the best and worst possible senses.
Sidney Wolfe continues to have many fans in medicine, and among the millions of readers of his Worst Pills, Best Pills books and newsletters. “Sid is, on one hand, a loose cannon, but on the other hand an enormous resource,” one prominent drug researcher told me. “He shoots from the hip, usually too early, but usually correctly. He serves an enormously important public role, although sometimes he goes beyond what the science will support. Some former supporters, however, think he has gone over the edge. “I think he has become hysterical and flaming enough that he undercuts the cause,” said another drug researcher.
“Sid Wolfe is not a positive force, because he sees drug companies as evil,” one drug safety analyst told me, “and without for-profit drug companies, we’d still be treating headaches by sucking on tree bark.”
Love him or hate him, Wolfe is still the most cunning and fearless free safety in the drug game, always the last guy a pharmaceutical company has to get by before scoring a commercial touchdown. He has made more than his share of game-ending open-field tackles.
Wolfe credits three events in his young adulthood for his medical activism. As an undergraduate in chemical engineering, the Ohio native worked two summers at a chemical plant on the Cuyahoga River (which itself became famous for catching fire) and regularly came home with burns on his hands from the acid they were manufacturing. After college he took a year off and worked in the local coroner’s office, where he became acutely aware of how often prescription drugs caused death — and not just in suicides. Then, during medical school, he worked in a hematology lab where they were studying bone marrow suppression caused by the antibiotic chloramphenicol.
By the mid-60s, Wolfe was a researcher at NIH, studying alcohol withdrawal and following a fairly traditional academic medicine track until he met Ralph Nader, who was just becoming known for consumer activism. Wolfe’s first major consumer action, in early 1971, was against Abbott Laboratories, which controlled much of the U.S. market for intravenous fluids. Some of the fluids had become contaminated with bacteria, but the company was reluctant to take them off the market and the FDA hadn’t forced the issue; it had simply warned doctors that any patient who got the infection should be taken off the Abbott IV fluid. Wolfe and Nader hand-delivered a letter demanding a recall to the chairman of the FDA and released it to the news media. Abbott announced a recall the next day, and Sid Wolfe, although he didn’t know it at the time, had launched a new career.
Nader’s umbrella organization Public Citizen was founded the next fall, on the day that Wolfe and Nader demanded the recall of all products colored with Red Dye #2. And, by the fall of 1972, Wolfe had left the NIH to run the Public Citizen Health Research Group full-time, raising as much medical hell as possible. He developed a true gift for repackaging large, shapeless public health concerns into media-friendly and sometimes even commercially saleable form. Who else but Sid Wolfe would have thought to take the government’s own list of older medications that, years after efficacy testing was mandated by the 1962 Kefauver-Harris bill, still hadn’t been officially proven effective, and publish it as a book (in 1980) under the catchy title Pills That Don’t Work? The book is a perfect example of what Wolfe does best: take already published material from the most credible sources and use it against drug companies, the FDA or prescribing doctors.
Wolfe burst into the small conference room and greeted me by saying, “You have fifteen minutes.” Tall and ruggedly handsome, with wavy brown hair, horn-rimmed glasses and a seriously cleft chin, he has an air of intense impatience about him, and his know-it-all edginess can be contagious, making a visitor feel the need to verbally joust. I told him I had been looking into Omniflox and asked him why he had never pursued the drug. He launched into a rapid-fire description of all the drugs he had moved on over the years.
“There are a number of drugs on the market for less than a year that wind up being taken off the market after dozens of deaths and hundreds of injuries,” he said. “There are some we sued the FDA to get off the market, like Suprol [suprofen], an anti-inflammatory drug used for pain from athletic injuries that caused several hundred cases of acute renal failure. And in each of these instances there was enough information, or should have been, prior to approval to stop the approval. In an increasing number of cases it turns out that information was criminally withheld from FDA…a pattern of withholding data. There is no evidence right now that Abbott withheld data. We got the adverse reaction reports and none of them seemed to have illegally long intervals between the reactions and the reports…
“We are besieged with things to work on…and when we looked at the Omniflox documents, nothing screamed out. Usually, on the things we pursue, the documents scream…but, I must underscore, I haven’t looked extensively at the drug.”
He did, however, have a general rule of thumb on these types of cases. “The sage position I choose to take,” he said, “is when something like this happens, I believe that until evidence to the contrary arises, there’s a strong suspicion that a company has withheld information from FDA or something else in the process has gone wrong. There are these instances where one in a million people gets a rare reaction that nobody could have anticipated and, lo and behold, when it gets into wide use three or four people get killed. I acknowledge there might be circumstances like that. But most of these events are hardly rare.”
Then he looked at his watch. “I can give you five more minutes,” he said.
Posted 1/2/2024 in memory of Sid, who died New Year’s Day at the age of 86.
